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Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) disorders in the United States. The company's product pipeline includes AXS-05, a therapeutic for the treatment of major depressive disorder and resistant depression disorders; and that is in the Phase III clinical trial to treat Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation. It is also developing AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine that has completed two Phase III trials for the acute treatment of migraine; AXS-12, a selective and potent norepinephrine reuptake inhibitor, which is in Phase III trial to treat narcolepsy; and AXS-14, a novel, oral, and investigational medicine that is in Phase III trial for the treatment of fibromyalgia. Axsome Therapeutics, Inc. has a research collaboration agreement with Duke University for evaluating AXS-05 in smoking cessation. The company was incorporated in 2012 and is based in New York, New York.

Axsome Therapeutics, Inc.

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NEW DRUG APPLICATION (NDA) SUBMISSION ON TRACK FOR JANUARY 2026 NEW YORK, DEC. 31, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT HAS RECEIVED FORMAL PRE-NEW DRUG APPLICATION (NDA) MEETING MINUTES FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) SUPPORTING AN NDA SUBMISSION FOR AXS-12 IN NARCOLEPSY. AXS-12 (REBOXETINE) IS A HIGHLY SELECTIVE AND POTENT NOREPINEPHRINE REUPTAKE INHIBITOR AND CORTICAL DOPAMINE MODULATOR.

AXSOME THERAPEUTICS ANNOUNCES FDA PRE-NDA MEETING MINUTES FOR AXS-12 IN NARCOLEPSY SUPPORTING NDA SUBMISSION

NEW YORK, NOV. 20, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT WILL PARTICIPATE IN THE FOLLOWING UPCOMING INVESTOR CONFERENCES IN DECEMBER:

AXSOME THERAPEUTICS TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES

AXSOME OBTAINS EXCLUSIVE GLOBAL RIGHTS TO AZD7325, A NOVEL ORAL SELECTIVE GABA A 2,3 RECEPTOR POSITIVE ALLOSTERIC MODULATOR

AXSOME THERAPEUTICS ACQUIRES SUBTYPE SELECTIVE GABA-A RECEPTOR POSITIVE ALLOSTERIC MODULATOR AZD7325 FOR THE TREATMENT OF EPILEPSY

MIAMI, NOV. 06, 2025 (GLOBE NEWSWIRE) -- AVENUE THERAPEUTICS, INC. (OTC: ATXI) (AVENUE OR THE COMPANY), A SPECIALTY PHARMACEUTICAL COMPANY FOCUSED ON THE DEVELOPMENT AND COMMERCIALIZATION OF THERAPIES FOR THE TREATMENT OF NEUROLOGIC DISEASES, AND ITS MAJORITY-OWNED SUBSIDIARY, BAERGIC BIO, INC. (BAERGIC), TODAY ANNOUNCED THAT AVENUE HAS ENTERED INTO AN AGREEMENT FOR BAERGIC TO BE ACQUIRED BY AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM) (AXSOME), INCLUDING THE GLOBAL RIGHTS TO BAER-101 (ALSO KNOWN AS AZD7325), A NOVEL ORAL GABAA 2,3 SUBTYPE-SELECTIVE RECEPTOR POSITIVE ALLOSTERIC MODULATOR (PAM). BAER-101 WAS ORIGINALLY LICENSED BY BAERGIC FROM ASTRAZENECA AB (ASTRAZENECA) AND WILL BE REFERRED TO AS AXS-17 BY AXSOME GOING FORWARD.

AVENUE THERAPEUTICS ANNOUNCES ACQUISITION OF SUBSIDIARY BAERGIC BIO BY AXSOME THERAPEUTICS

NEW YORK--(BUSINESS WIRE)--HALPER SADEH LLC, AN INVESTOR RIGHTS LAW FIRM, IS INVESTIGATING WHETHER CERTAIN OFFICERS AND DIRECTORS OF AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM) BREACHED THEIR FIDUCIARY DUTIES TO SHAREHOLDERS. IF YOU CURRENTLY OWN AXSOME STOCK AND ARE A LONG-TERM SHAREHOLDER, YOU MAY BE ABLE TO SEEK CORPORATE GOVERNANCE REFORMS, THE RETURN OF FUNDS BACK TO THE COMPANY, A COURT-APPROVED FINANCIAL INCENTIVE AWARD, OR OTHER RELIEF AND BENEFITS. PLEASE CLICK HERE TO LEARN MORE ABOUT YO.

HALPER SADEH LLC ENCOURAGES AXSOME THERAPEUTICS, INC. SHAREHOLDERS TO CONTACT THE FIRM TO DISCUSS THEIR RIGHTS

NEW YORK, OCT. 09, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED IT IS RECOGNIZING MENTAL ILLNESS AWARENESS WEEK (MIAW) ALONGSIDE THE NATIONAL MENTAL HEALTH ADVOCACY COMMUNITY INCLUDING THE NATIONAL ALLIANCE ON MENTAL ILLNESS (NAMI). THIS YEAR'S THEME FOR MIAW IS BUILDING COMMUNITY: SUPPORTING MENTAL WELL-BEING TOGETHER, TO HIGHLIGHT THE IMPORTANCE OF MEANINGFUL CONNECTIONS, THE VALUE OF GRASSROOTS ADVOCACY, AND IMPACT OF LOCAL ACTION TO STRENGTHEN MENTAL HEALTH SUPPORT WITHIN COMMUNITIES.

AXSOME THERAPEUTICS RECOGNIZES MENTAL ILLNESS AWARENESS WEEK ALONG WITH THE NATIONAL ADVOCACY COMMUNITY

NEW YORK, OCT. 07, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED IT WILL REPORT ITS FINANCIAL RESULTS FOR THE THIRD QUARTER OF 2025 ON MONDAY, NOVEMBER 3, 2025, BEFORE THE OPENING OF THE U.

AXSOME THERAPEUTICS TO REPORT THIRD QUARTER 2025 FINANCIAL RESULTS ON NOVEMBER 3

SIX POSTER PRESENTATIONS SHOWCASE CLINICAL AND REAL-WORLD DATA IN MAJOR DEPRESSIVE DISORDER, ALZHEIMER'S DISEASE AGITATION, NARCOLEPSY, AND OBSTRUCTIVE SLEEP APNEA SIX POSTER PRESENTATIONS SHOWCASE CLINICAL AND REAL-WORLD DATA IN MAJOR DEPRESSIVE DISORDER, ALZHEIMER'S DISEASE AGITATION, NARCOLEPSY, AND OBSTRUCTIVE SLEEP APNEA

AXSOME THERAPEUTICS HIGHLIGHTS DATA ACROSS ITS LEADING NEUROSCIENCE PIPELINE AT PSYCH CONGRESS 2025

TOTAL 2Q 2025 NET PRODUCT REVENUE OF $150.0 MILLION, REPRESENTING GROWTH OF 72% YEAR-OVER-YEAR AND 24% SEQUENTIALLY AUVELITY  2Q 2025 NET PRODUCT SALES OF $119.6 MILLION, REPRESENTING GROWTH OF 84% YEAR-OVER-YEAR AND 24% SEQUENTIALLY SUNOSI  2Q 2025 NET PRODUCT REVENUE OF $30.0 MILLION, REPRESENTING GROWTH OF 35% YEAR-OVER-YEAR AND 19% SEQUENTIALLY SYMBRAVO  LAUNCHED JUNE 10 TH , WITH 2Q 2025 NET PRODUCT SALES OF $0.4 MILLION AUVELITY  MARKET ACCESS EXPANDED BY 28 MILLION NEW COVERED LIVES IN THE COMMERCIAL CHANNEL FIRST GROUP PURCHASING ORGANIZATION (GPO) CONTRACT FOR SYMBRAVO  SIGNED SUPPLEMENTAL NDA SUBMISSION FOR AXS-05 IN ALZHEIMER'S DISEASE AGITATION ON TRACK FOR 3Q 2025 NDA SUBMISSION FOR AXS-12 FOR CATAPLEXY IN PATIENTS WITH NARCOLEPSY ANTICIPATED IN 4Q 2025 COMPANY TO HOST CONFERENCE CALL TODAY AT 8:00 AM EASTERN NEW YORK, AUG. 04, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED FINANCIAL RESULTS FOR THE SECOND QUARTER OF 2025 AND PROVIDED A GENERAL BUSINESS UPDATE. AXSOME DELIVERED ROBUST SECOND QUARTER PERFORMANCE, REFLECTING STRONG UNDERLYING DEMAND FOR OUR LIFE-CHANGING MEDICINES, EXACTING COMMERCIAL EXECUTION, SOLID REGULATORY PROGRESS, AND CONTINUED ADVANCEMENT OF OUR DIFFERENTIATED NEUROSCIENCE PIPELINE.

AXSOME THERAPEUTICS REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

COMPREHENSIVE REVIEW OF BROAD PIPELINE TARGETING ALZHEIMER'S DISEASE AGITATION, DEPRESSION, NARCOLEPSY, FIBROMYALGIA, ADHD, AND SMOKING CESSATION, WITH NEW DATA ANALYSES

AXSOME THERAPEUTICS HOSTS FRONTIERS IN BRAIN HEALTH R&D DAY REVIEWING INDUSTRY-LEADING LATE-STAGE CNS PIPELINE

NEW YORK, JULY 09, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED IT WILL REPORT ITS FINANCIAL RESULTS FOR THE SECOND QUARTER OF 2025 ON MONDAY, AUGUST 4, 2025, BEFORE THE OPENING OF THE U.S. FINANCIAL MARKETS. AXSOME MANAGEMENT WILL THEN HOST A CONFERENCE CALL AT 8:00 A.M. EASTERN TIME TO DISCUSS THESE RESULTS AND PROVIDE A BUSINESS UPDATE.

Axsome Therapeutics, Inc.

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Axsome Therapeutics, Inc.

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